The present invention relates to an external urinary catheter and collection system for use by an incontinent male. More specifically, the present invention relates to an external male urinary catheter and collection system that utilizes a negative pressure for retaining the sleeve-like catheter on the male penis and for collecting urine passed by the wearer.
A recent survey estimates that there are approximately 35 million incontinent adults in the United States. Of that number, approximately one-third are male and two-thirds are female. Most of the incontinent males are elderly, or have bladder or urinary tract diseases or may be spinal cord victims that have lost control of certain bodily functions. Incontinence is a physical problem that has severe psychological effects because of the fear of the incontinent person that an "incontinence accident" will occur in public with corresponding embarrassment and shame. Many incontinent persons refuse to go out in public and lead private reclusive lives because of the fear and stigma associated with a public "incontinence accident".
Many attempts have been made to overcome this problem, originally, by use of a catheter (classical medical definition) inserted into the urinary tract of the patient. However, long-term invasive catheter insertion almost universally leads to repeated urinary tract and bladder infections with the resulting need for treatment and removal of the catheter while the infection is treated. Such continuing infections also have a negative impact on the general health of the patient.
The "internally" inserted catheter referred to above is the type meeting the "classic" medical definition of a "catheter", as typically defined in Webster's Medical Desk Dictionary (Merriam Webster, Inc., 1986) as "a tubular medical device for insertion into canals, vessels, passageways, or body cavities usually to permit injection or withdrawal of fluids or to keep a passage open." Attempts at developing "external" catheters (non-invasive) for male patients have been tried, in which the "external" catheter is attached externally to the male penis and does not invade the urethra. The earliest and simplest of such "external catheter" utilizes a rubber, sleeve-like device similar to a condom that has a rubber tube attached to its distal end for drainage of urine. Other attempts have utilized various sheath-like devices for attachment to the male penis with drainage tubes and bags for collecting the urine.
A major problem has been encountered in attaching the apparatus to the male penis. A condom-like device will not stay attached to a male penis in a flaccid state unless some type of adhesive or tape is utilized. Prolonged use of an adhesive or tape causes skin rashes and irritations on the contacted skin of the penis. Such irritations often become painful and infected, thus limiting the use of the device. Some devices use a harness about the hips of the wearer for supporting the device on the penis, or an undergarment to which a sheath-like device is attached. However, the problem of maintaining a flaccid penis in the sheath-like portion of such devices persists.
Another problem associated with many of such prior art "external" catheters is that after voiding some urine often remains in the penile sheath in contact with the skin of the penis. Prolonged contact of urine and the penile skin also causes skin rashes and irritations that are painful and may lead to skin and urinary tract infections. No effective means of overcoming such a problem has been found for ambulatory males with an incontinence problem that will permit them a range of normal movement and activities.
Accordingly, one primary feature of the present invention is to provide an external male urinary catheter and collection system that is easy to attach, comfortable to wear and may be worn for extended periods of time without danger of irritation to the skin of the male penis.
Another primary feature of the present invention is to provide a sheath-like member for attachment to the male penis that is maintained in place by means of negative pressure without the need of adhesive or tape.
Still another feature of the present invention is to provide a negative pressure evacuation device communicating with the sheath-like member that will effect a negative pressure therein for causing the male penis to elongate in a simulated erection and provide sufficient surface area for effecting an airtight seal with the sheath-like member.
Another feature of the present invention is to provide a one-way urine drainage tube communicating between the sheath-like member and a negative-pressure evacuation device for permitting urine flow from the sheath-like member to the evacuation device for collection.
Still another feature of the present invention is to provide a one-way air pressure equalization tube communicating between a negative-pressure evacuation device and the sheath-like member for permitting equalization of the negative air pressure therebetween.